In the United States alone, over $1 billion is spent every year on prescribed medications that are never administered to patients due to waste. (See, B M J 2016; 352:i788 doi: 10.1136/bmj.i788 (Published 1 Mar. 2016.) As biological protein drugs (biologics) that require intravenous (IV) infusion become more prominent and replace orally-administered small molecule drugs, the amount of money wasted will continue to increase. For example, in 2015, 11 of the 45 new drugs approved by the Food and Drug Administration (FDA) were biologics, while only 6 of the 29 new drugs approved by the FDA in 2011 were biologics. In 2016, 7 of the 19 new drug approvals were biologics.
Biologics (as well as many other IV infused drugs) may ordinarily be dosed based on a patient's weight or based on a patient's estimated skin surface area to achieve a therapeutically effective concentration of drug while attempting to minimize the rate of severe adverse events for the patient and on the target tissue. Many of the biological protein drugs may be provided in single-use vials with only one or two volume sizes. Accordingly, a full patient-specific dose of a biological protein drug from single-use vials may often lead to an excess quantity of the drug remaining in the last vial after the full dose is administered. This excess drug quantity is currently discarded because sterility of the excess drug cannot be ensured for a reasonable period of time or upon re-penetrating the membrane or septum of the vial for use of the remaining drug in another patient.
For example, the drug, Avastin (generic name bevacizumab) is frequently used to treat many types of cancer. Avastin is currently sold in 100 mg and 400 mg single-use vials, yet the FDA has approved dose ranges from 5-15 mg/kg based on the tumor type. The FDA approved dose for lung cancer patients is 15 mg/kg dose of Avastin. A patient with lung cancer weighing 70 kg would require 1050 mg of Avastin for a full dose. Therefore, after the patient receives the full dose of Avastin, a minimum of 50 mg of excess Avastin will be remaining in the last vial. Recently published wholesale acquisition costs for Avastin indicate that 50 mg of Avastin costs approximately $360. Thus, discarding 50 mg of Avastin costs a patient, a hospital, or an insurance company, for example, approximately $360. Assuming the patient receives the 1050 mg dose of Avastin every two weeks for a year, approximately $9,360 of Avastin is wasted in treating that patient per year.
Accordingly, systems, apparatuses, and methods to maintain a sterile environment for a remaining portion of medicine from a vial after a portion of the medicine from the vial is extracted for use on a patient is provided. The systems, apparatuses, and methods provide a safe and reliable means to reduce drug waste and extend the beyond use date of medicine. It should be understood that the beyond use date may be the amount of time that a drug may be safely used before attaining an unsafe amount of contamination after the drug is reconstituted for use in a patient. It should also be understood that contamination may include at least one of microbial contamination, bacterial contamination, viral contamination, chemical contamination, or any other type of contamination known by those having ordinary skill in the art. In addition, the systems, apparatuses, and methods discussed herein may be used to reduce healthcare worker (such as a nurse or pharmacist) exposure to hazardous drugs, prevent leakage, and surface contamination from spills. In some cases, the systems, apparatuses, and methods may be used without the need for a biosafety cabinet providing the required amount of air changes during drug extraction. Such features may have a significant impact on public health services.